Enhance® PoGo® Polishing System
PoGo® One Step Diamond Micro-Polisher - Polishing Point Refill Package (40)
7manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | DZP |
| Device type | Instrument, Diamond, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4535 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2020-03-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry.; Storage environment temperature 10 to 27 °C |
| Packaging | Case of 6, box of 6 |
| Distribution end date | 2024-06-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 662022 | 30 Polishing Points | 40 | In distribution |
| 662024 | 1x polishing disc, 1x polishing point, 1x polishing cup | In distribution | |
| 662010Y | 30x polishing discs | 30 | In distribution |
| 662022Y | 30x polishing points | 30 | In distribution |
| 662023Y | 30x polishing cups | 30 | In distribution |
| 662010 | 30 Polishing Discs | 40 | In distribution |
| 662025Y | 10 Polishing Discs, 10 Polishing Points, 10 Polishing Cups | In distribution | |
| 662023 | 40x polishing cups | 40 | In distribution |
| 662024 | 1 Polishing Disc, 1 Polishing Point, 1 Polishing Cup | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MDT Diamond Coated Dental Burs | M.D.T. – Micro Diamond Technologies Ltd. | 31,050 |
| MDT Diamond Coated Dental Burs -Sterile | M.D.T. – Micro Diamond Technologies Ltd. | 3,719 |
| FG diamond | DFS-Diamon Gmbh | 2,527 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 2,320 |
| Two Striper | Abrasive Technology, LLC | 2,294 |
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 2,240 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 2,016 |
| Edenta | Edenta Etablissement | 1,831 |
| Instrument, Diamond, Dental | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 1,827 |
| Jota | Jota AG | 1,615 |
| Komet Dental Diamond Instruments | Gebr. Brasseler Gmbh & Co. KG | 1,610 |
| dental diamond bur | Strauss & Co – Industrial Diamonds Ltd | 1,456 |
Showing 12 of 366. All products under Instrument, Diamond, Dental
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.